Archive for the ‘Uncategorized’ category

MedImmune FDA advisory Committee for motavizumab

April 15th, 2010
June 2, 2010

Medimmune LLC meets with FDA Antiviral Committee for motavizumab

May 26th, 2010
June 2, 2010

Delcath and ArQule Releases Non-Public data at ASCO 12:00 PM June 5, 2009

May 26th, 2010
June 5, 2010

http://abstract.asco.org/AbstView_74_53424.html

Novartis Pharmaceuticals FDA adviosry meeting for GILENIA

April 15th, 2010
June 10, 2010

Novartis Meets with the Peripheral and Central Nervous System Drugs Advisory Committee to discuss GILENIA

May 26th, 2010
June 10, 2010

The committee will discuss new drug application (NDA) 22-527, with the proposed trade name GILENIA (fingolimod hydrochloride) 0.5 milligram (mg) capsules, by Novartis Pharmaceuticals Corporation. The proposed indication for this new drug product is treatment of relapsing forms of multiple sclerosis.

Laboratoire HRA Pharma meets with Reproductive Health Drugs Advisory Committee to discuss ulipristal acetate tablets

May 26th, 2010
June 17, 2010

The committee will discuss new drug application (NDA) 22-474, ulipristal acetate tablets, 30 milligrams (mg), by Laboratoire HRA Pharma. Ulipristal is an emergency contraceptive for the proposed indication of the prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.

Genzyme (GENZ): Lumizyme PDUFA date, June 17, 2010

April 21st, 2010
June 17, 2010

Boehringer Ingelheim Pharmaceuticals meets with the Reproductive Health Drugs Advisory Committee to discuss flibanserin tablets

May 26th, 2010
June 18, 2010

The committee will discuss new drug application (NDA) 22-526, flibanserin 100 milligram (mg) tablets, by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed indication of the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.